MedPath
FDA Approval

MILK OF MAGNESIA ORIGINAL

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 23, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Magnesium hydroxide(1200 mg in 15 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

MILK OF MAGNESIA ORIGINAL

Product Details

NDC Product Code
17856-0788
Application Number
M007
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
May 23, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYPOCHLORITEInactive
Code: DY38VHM5ODClass: IACT
Code: NBZ3QY004SClass: ACTIBQuantity: 1200 mg in 15 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID

image 1


INDICATIONS & USAGE SECTION

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours

DOSAGE & ADMINISTRATION SECTION

Directions

• shake well before use • do not exceed the maximum recommended daily dose in a 24 hour period • dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor • drink a full glass (8 oz) of liquid with each dose adults and children 12 years and older: 2 to 4 tablespoonfuls (TBSP) children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP) children under 6 years: ask a doctor


WARNINGS SECTION

Warnings

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet
  • stomach pain, nausea, or vomiting
  • a sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are taking a prescription drug.

This product may interact with certain prescription drugs.

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.Keep out of reach of children.


STORAGE AND HANDLING SECTION

Other information

• magnesium 500 mg • store at room temperature and avoid freezing • close cap tightly after use •each 15 mL tablespoonful contains:

TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.


OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 15 mL)

Magnesium hydroxide 1200 mg

OTC - PURPOSE SECTION

Purpose

Saline laxative


INACTIVE INGREDIENT SECTION

Inactive ingredients

purified water, sodium hypochlorite


© Copyright 2025. All Rights Reserved by MedPath